A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis (GPP)

A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects With Generalized Pustular Psoriasis

The main objectives of this study are to evaluate the efficacy, safety and tolerability of imsidolimab in adults with active GPP.

Study Overview

• Status: Completed
• Conditions: Generalized Pustular Psoriasis
• Intervention / Treatment: Biological: Imsidolimab

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Site 501
• Poland
  • Olsztyn, Poland, 10-229
    • Site 304
  • Rzeszów, Poland, 35-055
    • Site 301
  • Łódź, Poland, 90-436
    • Site 303
  • Łódź, Poland
    • Site 302
• United Kingdom
  • London, United Kingdom
    • Site 201
  • Newcastle Upon Tyne, United Kingdom
    • Site 203
  • Salford, United Kingdom
    • Site 202
• United States
  • California
    • Encino, California, United States, 91436
      • Site 102
  • Florida
    • Largo, Florida, United States, 33771
      • Site 105
    • Miami, Florida, United States, 33316
      • Site 104
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Site 101
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Site 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of active GPP
• Japanese Dermatology Association (JDA) severity index total score of at least 6 and erythema with pustules accounting for at least 10% of body surface area or a moderate severity score on Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA)
• Must be candidates for systemic therapy or phototherapy

Exclusion Criteria:

• Erythrodermic, guttate psoriasis, drug induced GPP
• Any other ongoing inflammatory disease that interfere with the Investigator's ability to evaluate the subject's response to therapy
• History of recurrent or chronic infection
• ongoing use of psoriasis prohibited medication

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imsidolimab; Participants received imsidolimab 750 mg intravenously (IV) on Day 1 followed by administration of 3 doses of subcutaneous (SC) imsidolimab 100 mg on Days 29, 57, and 85.	Biological: Imsidolimab; Humanized monoclonal antibody; Other Names: ANB019

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Response on the Clinical Global Impression (CGI) Scale	Clinical response was defined as "Very much improved," "Much Improved," or "Minimally Improved" on the CGI scale according to the Modified Japanese Dermatological Association Severity Index (JDA-SI) total score. The JDA-SI includes assessment of skin lesions (area of erythema with pustules, area of erythema total, and area of edema) and fever, white blood cell count, C-reactive protein and serum albumin levels. The total score ranges from 0 to 17 (severe). CGI was assessed based on the JDA-SI according to the following: Very Much Improved: Reduction in JDA-SI total score by 3 or > points;; Much improved: Reduction in JDA-SI total score by 1 or 2 points;; Minimally improved: No change in JDA-SI total score and area of erythema with pustules reduced by <20% or clinically meaningful improvement in at least 1 other component of the modified JDA-SI.	Week 4 and Week 16
Percent Change From Baseline in Body Surface Area of Erythema With Pustules at Week 1, Week 4, and Week 16		Baseline, Week 1, Week 4, and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Modified Japanese Dermatological Association - Severity Index (mJDA-SI) Total Skin Lesions Score at Week 1, Week 4, and Week 16	The area of erythema with pustules, area of total erythema and area of edema were assessed by the Investigator and scored from 0 to 3 on the following scale: 0: 0% body surface area (BSA) affected;; 1: > 0%, < 10% BSA affected;; 2: ≥ 10%, < 50% BSA affected;; 3: ≥ 50% BSA affected. The JDA-SI Total Skin Lesions Score is the sum of the area of erythema with pustules score, area of total erythema score and area of edema score and ranges between 0 and 9 (worst). A negative change from Baseline indicates improvement.	Baseline, Week 1, Week 4, and Week 16
Percentage of Participants Achieving a Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) Score of 0 or 1 at Week 1, Week 4, and Week 16	The GPPPGA scale was used to assess the impact and severity of GPP on the following scale: 0: Clear (normal skin or post-inflammatory hyperpigmentation, no visible pustules, no scaling or crusting).; 1: Almost clear (faint, diffuse pink or slight red erythema, low density occasional small discrete pustules (noncoalescent), superficial focal scaling or crusting restricted to periphery of lesions).; 2: Mild (light red erythema, moderate density grouped discrete small pustules (noncoalescent), predominantly fine scaling or crusting).; 3: Moderate (bright red erythema, high density pustules with some coalescence, moderate scaling or crusting covering most or all lesions).; 4: Severe (deep fiery red erythema, very high density pustules with pustular lakes, severe scaling or crusting covering most or all lesions).	Week 1, Week 4, and Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 1, Week 4, and Week 16	The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.	Baseline and Week 1, Week 4, and Week 16

Collaborators and Investigators

• Sponsor: AnaptysBio, Inc.
• Investigators: Study Director: Irina Khanskaya, MD, AnaptysBio, Inc.

Publications and helpful links

Helpful Links

• Related Information

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: GPP
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ANB019-002; 2017-004021-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No